Vectibix - instructions for use, analogs, testimonials and release forms (injections in injectable ampoules or infusion concentrate 100 mg, 200 mg and 400 mg) of the drug for the treatment of colorectal cancer in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Vectibix. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Vectibix in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Vectibix in the presence of existing structural analogs.Use for the treatment of cancer of the rectum and colon in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Vectibix - human monoclonal antibody IgG2, derived from the mammalian cell line (Chinese hamster ovary) by recombinant DNA technology (DNA - deoxyribonucleic acid). Panitumumab (active ingredient of Vectibix) has a high affinity and specificity for human epithelial growth factor (EGF) receptors. The EGF receptor is a transmembrane glycoprotein from the receptor family of Type I tyrosine kinases, which also includes HER1 / c-ErbB-1, HER2, HER3, and HER4. The EGF receptor stimulates the growth of normal epithelial cells, including skin cells and hair follicles, and is expressed on various types of tumor cells.

Vectibix binds to the ligand-binding domain of the EGF receptor and inhibits the autophosphorylation process, which is induced by all known EGF receptor ligands. The binding of panitumumab to the EGF receptor leads to internalization of the receptor, inhibition of cell growth processes, induction of apoptosis, and a decrease in interleukin-8 production and a vascular endothelial growth factor.The KRAS gene (the homologue of the viral oncogene of rat karsten sarcoma 2) encodes a small guanosine triphosphate-binding protein that is involved in transduction of the signal. KRAS is activated by various signals, including from the EGF receptor, and, in turn, stimulates the synthesis of other intracellular proteins involved in cellular proliferation, survival and angiogenesis. Activating mutations of the KRAS gene often occur in various human tumor cells and play a role, both in the course of oncogenesis and in the progression of the tumor.

Composition

Panitumumab + auxiliary substances.

Pharmacokinetics

When Vectibix is ​​prescribed as a monotherapy or in combination with chemotherapy, the pharmacokinetics of the drug is non-linear. Based on the results of the analysis of pharmacokinetics, the age, sex of the patient, race, liver and kidney function, the use of concomitant chemotherapeutic drugs and the expression of receptors of epithelial growth by tumor cells do not exert an obvious effect on the pharmacokinetics of panitumumab in certain groups of patients (mainly aged 21-88 years).Studies of the pharmacokinetics of panitumumab in patients with impaired renal or hepatic function were not performed.

Indications

• metastatic colorectal cancer (including colon cancer, rectal cancer, cancer of the rectosigmoid connection) with the expression of the EGF receptor and non-mutated (wild) type KRAS - monotrapiya with disease progression on the background or after prior chemotherapy course fluoropyrimidin, oksaliplatin- and irinotekan- containing modes.

Forms of release

Concentrate for solution for infusion is 100 mg in 5 ml, 200 mg in 10 ml, 400 mg in 20 ml (injections in ampoules for injection).

Instructions for use and dosing regimen

The recommended dose of Vectibix is ​​6 mg per 1 kg of body weight once every 2 weeks.

The safety and efficacy of Vectibix have not been evaluated in patients with impaired renal or hepatic function.

In the case of prescribing elderly patients, dose adjustment is not required.

Experience in the use of Vectibix in children is absent, so the drug should not be prescribed to patients under 18 years of age.

Recommendations for dose adjustment and administration

When a weak or moderate signs of infusion reaction (grade 1 or 2), reduce the injection rate at 50%.If there are severe symptoms of the infusion reaction (degree 3 or 4), the introduction of Vectibix should be stopped immediately.

With the development of a dermatological reaction of 3 or higher severity or regarded by the patient as an "intolerable dermatological reaction," Vectibix should be temporarily suspended until the severity of this reaction is reduced. After reducing the severity of the observed dermatological reaction to a maximum of 2 degrees, the introduction of Vectibix is ​​resumed at a dose equal to 50% of the original. In the absence of repeated development of the reaction, the dose of Vectibix should be gradually increased by 25% until the recommended dose is reached. If the severity of the reaction does not decrease (to 2 degrees of severity or less) after skipping 1 or 2 doses of Vectibix, or in case of relapse or the appearance of an intolerable reaction at a dose of 50% of the initial dose, Vectibix preparation should be completely discarded.

Instructions for the preparation and administration of a solution for infusions

Before the infusion, Vectibix is ​​diluted in a 0.9% solution of sodium chloride for injection using aseptic dilution technique.It is not recommended to shake or vortex the bottle vigorously. Do not administer the drug if there is a discoloration of the contents of the vial. From the vial with the drug, the required amount of Vectibix is ​​taken to obtain a dose of 6 mg per kg, which is then dissolved in a total volume of 100 ml. The final concentration should not exceed 10 mg in 1 ml. Doses higher than 1000 mg should be dissolved in 150 ml of a 0.9% solution of sodium chloride for injection. The resulting solution is mixed by carefully turning the vial, do not shake.

Vectibix should be administered intravenously via an infusion pump to the peripheral probe or a permanent catheter through an integrated 0.2 or 0.22 micron filter with a low degree of protein binding. The recommended duration of the infusion is approximately 60 minutes. The duration of administration of the drug in doses above 1000 mg should be approximately 90 minutes.

Before and after administration of Vectibix, the infusion system must be rinsed with saline to avoid mixing Vectibix with other drugs or solutions for intravenous administration. It is not recommended jet or bolus Vektibiksa introduction.

Side effect

• paronychia (inflammation of the okolonogtevogo roller);
• pustular (pustular) rash;
• cellulite (structural changes in the subcutaneous layer);
• sepsis;
• eye infection, eyelid infection;
• Acne rash, acne;
• erythema (severe reddening of the skin caused by the expansion of capillaries);
• skin peeling;
• exfoliative rash;
• itching;
• dry skin, skin cracks;
• acneiform dermatitis;
• papular rash, erythematous rash, macular rash, maculopapular rash, itching rash;
• skin ulcers;
• diseases of the nails (onychoclasia, onycholysis);
• hypertrichosis (excessive hair growth), alopecia (alopecia);
• scabies;
• angioedema (edema of Quincke);
• diarrhea, constipation;
• nausea, vomiting;
• abdominal pain;
• stomatitis;
• dryness of the oral mucosa, nose;
• shortness of breath, cough;
• nasal bleeding;
• pulmonary embolism;
• bronchospasm;
• conjunctivitis (inflammation of the mucous membrane of the eye);
• increased lacrimation;
• hyperemia of the eyeball;
• dryness and irritation of the eyes, irritation of the eyelids;
• itching of the eyes;
• increased eyelash growth;
• headache, dizziness;
• hypomagnesemia, hypocalcemia, hypokalemia;
• dehydration;
• infusion reactions that develop within 24 hours after the infusion: abdominal pain, anaphylactic reactions, angioedema, back pain, bronchospasm, cardiac arrest, chest pain, chills, cyanosis, dyspnea, flushing, hypertension, hypotension, pyrexia ( fever), tachycardia, vomiting;
• increased fatigue.

Contraindications

• life-threatening hypersensitivity reactions to any of the components of the drug in the anamnesis;
• interstitial pneumonitis or pulmonary fibrosis;
• children's age (efficacy and safety in children under 18 years old not established);
• pregnancy;
• the period of lactation.

Application in pregnancy and lactation

The EGF receptor is involved in the control of prenatal development of the fetus and plays a role in the processes of normal organogenesis, proliferation and differentiation of the cells of the developing embryo. Thus, Vectibix may have potential harm to the fetus when given to pregnant women. It is known that human antibodies immunoglobulin G (IgG) are able to penetrate the placental barrier, so panitumumab can penetrate from the mother's body into the developing fetus.Therefore, women with a safe reproductive function during Vectibiks treatment and within 6 months after the end of it should use reliable contraceptives. If the pregnancy has developed against the background of therapy, it is necessary to explain to the patient the potential risk of abortion and the potential risk to the fetus.

It is unknown whether panitumumab passes into breast milk. Since human IgG antibodies penetrate breast milk, it can be assumed that panitumumab can also penetrate into breast milk. The possibility of absorption of the drug and its potential harm to the child are not established. During the treatment with Vectibix and within 3 months after its end, breast-feeding is not recommended.

In experimental studies, a reversible effect of the drug on the menstrual cycle and a decrease in the fecundity of monkey females was shown. In this regard, panitumumab may affect the possibility of developing pregnancy in women.

Use in children

Contraindicated in children and adolescents under 18 years.

Application in elderly patients

If the drug is prescribed for older people, dose adjustment is not required.

special instructions

Vectibix treatment should be performed under the supervision of a doctor who has experience in prescribing antitumor drugs.

Determination of the expression of the non-mutated KRAS should be performed by experienced laboratory technicians using a validated methodology.

Dermatological reactions

Dermatological reactions (class effect of EGF receptor inhibitors, caused by pharmacological properties) were observed in practically all patients (approximately 90%) who received Vectibix.

Patients who developed severe dermatological reactions or worsened during the course of Vectibiksome treatment for other dermatological reactions should be observed for the development of inflammatory or infectious complications (including cellulitis); if necessary, such patients should be prescribed appropriate treatment. During treatment with Vectibix and with the development of dermatological reactions, including skin rashes, it is recommended to use sunscreen and headwear, since sunlight can enhance the severity of dermatological reactions that occur when the drug is used.

Complications from the lungs

Interstitial lung diseases have arisen against the background of therapy with other inhibitors of the EGF receptor, therefore, if there is or worsening of pulmonary symptoms, Vectibix treatment should be stopped and the symptoms observed are immediately and thoroughly examined. If a pneumonitis or infiltrates is found in the lung tissue, Vectibix should be discarded and appropriate treatment should be prescribed.

Violations of electrolyte balance

Some patients showed a progressive decrease in serum magnesium concentrations, leading to severe (grade 4) hypomagnesemia. Periodic monitoring of the patients' condition for the development of hypomagnesemia and concomitant hypocalcemia is necessary every 2 weeks during Vectibiks treatment and within 8 weeks after its termination. Recommended intake of magnesium preparations (if necessary).

There were also violations of the balance of other electrolytes, including hypokalemia. It is recommended that serum concentrations of other electrolytes be adequately maintained.

The preparation contains 0.15 mmol of sodium (corresponding to 3.45 mg of sodium) per 1 ml of concentrate.In this regard, patients who adhere to a diet with a reduced sodium content during the treatment should control the amount of sodium in their diet.

Infusion reactions

In a clinical trial, 4% of patients had infusion reactions, while in 1% of patients these reactions were classified as severe (grades 3 and 4). In all clinical studies, infusion reactions (occurring within 24 hours after any infusion) were seen in 3% of patients who received Vectibix, of which less than 1% were severe (grades 3 and 4). Post-marketing studies reported serious infusion reactions, including rare post-marketing reports with a fatal outcome. You should stop the infusion in the event of a severe or life-threatening reaction (for example, if there is bronchospasm, angioedema, hypotension or anaphylaxis). Depending on the severity and / or duration of the reaction, the issue of permanent withdrawal of Vectibix should be addressed.

In patients with mild or moderate (grade 1 and 2) infusion reactions, the rate of infusion should be reduced throughout the infusion.It is recommended to maintain a reduced rate of infusion during all subsequent infusions.

Hypersensitivity reactions occurred more than 24 hours after infusions, including angioedema, which developed fatal after more than 24 hours after infusion. Patients should be warned about the possibility of late development of the reaction and should be instructed to consult their physician if symptoms of a hypersensitivity reaction occur.

Vectibix in combination with regimens of chemotherapy

With the use of Vectibix in combination with bevacizumab and regimens of chemotherapy on the basis of irinotecan, fluoropyrimidines and calcium folinate (leucovorin) (IFL), there was a significant increase in the incidence of pulmonary embolism, infectious complications (mainly of dermatological origin), diarrhea, electrolyte balance and dehydration. Additional analysis of efficacy data, depending on the status of KRAS, did not reveal the benefits of adding Vectibix to chemotherapy regimens based on oxaliplatin or irinotecan and bevacizumab.There was a trend towards a decrease in survival in groups on regimes containing oxaliplatin or irinotecan, regardless of the status of the KRAS mutation.

In this regard, it is necessary to avoid the combination of Vectibix with chemotherapy regimens containing bevacizumab.

Vectibix in combination with oxaliplatin-based chemotherapy in the treatment of patients with metastatic colorectal cancer (mCRC)

Vectibix should not be given in combination with chemotherapy containing oxaliplatin, patients with mCRC, with tumors characterized by mutant KRAS, or in case of an unspecified status of KRAS tumor. In phase 3 studies (n = 1183, 656 patients with wild type KRAS and 440 patients with mutated KRAS type in tumors), according to the evaluation of panitumumab in combination with infusion 5-fluorouracil, leucovorin (FOLFOX), compared with FOLFOX only as therapy the first line in mCRC in patients with tumors with mutated KRAS, receiving panitumumab and FOLFOX (n = 221) compared with FOLFOX alone (n = 219), showed a reduction in progression-free survival of the overall survival time.

Acute kidney failure

Acute renal failure was noted in patients with severe diarrhea and dehydration.

Impact on the ability to drive vehicles and manage mechanisms

Special studies of the effect of the drug on the ability to drive vehicles and use complex equipment were not conducted. If undesirable reactions from the visual organs develop and / or reduce the ability to concentrate and respond quickly, patients are advised to refrain from driving vehicles or working with complex equipment prior to resolving these unwanted reactions of the drug.

Drug Interactions

There were no studies of drug interactions.

The combined use of Vectibix with regimens of IFL or regimens of chemotherapy involving bevacizumab is not recommended. With the appointment of panitumumab in combination with a chemotherapy regimen including bevacizumab, there was an increase in mortality.

Vectibix should not be given in combination with oxaliplatin-containing chemotherapy, patients with tumors characterized by a mutant KRAS, or in case of an unspecified status of a KRAS tumor. In a clinical trial, patients with tumors with mutated KRAS receiving panitumumab and FOLFOX had a reduction in progression-free survival of the overall survival time.

Analogues of the drug Vectibix

Structural analogues for the active ingredient do not have Vectibix.

Analogues of the drug for the pharmacological group (antitumor agents - monoclonal antibodies):

• Avastin;
• Avegra;
• Adzetris;
• Arzerra;
• Acellbia;
• Bevacizumab;
• Beyodeim;
• Blintsito;
• Gaziva;
• Gertikad;
• Herceptin;
• Darzaleks;
• Ervoi;
• Cadsi;
• Citrada;
• Cosentix;
• Campas;
• Lemtrada;
• MabThera;
• Ocervus;
• Opdyvo;
• Perieta;
• Redditus;
• Removab;
• Rituximab;
• Symphony;
• Tecentric;
• Tizabry;
• Trastuzumab;
• Tsiramza;
• Emplicity;
• Erbitux.

Analogues on the curative effect (remedies for the treatment of colon cancer):

• 5-Fluorouracil;
• Avastin;
• Hydroxyurea;
• The sunburn;
• Irinotecan;
• Irinotel;
• Iritin;
• Irkokam;
• Kabetsin;
• Campto;
• Xeloda;
• Leucovorin;
• Mitomycin;
• Natriopholin;
• Oxaliplatin;
• Oxitane;
• Steiverg;
• Tomoudex;
• Ftorafur;
• Tsiramza;
• The Exorcise;
• Eloxatin;
• Epirubicin;
• Epindandan.

Review of the oncologist's doctor

Vektibiks preparation in our department we use for treatment of colorectal cancer, but not often. This is due to the fact that in our practice there have been and are cases of development during the treatment of this drug of very serious adverse reactions, especially from the skin, hair and nails.They manifest themselves as massive, different in morphology skin rashes, paronychia, the appearance of ulcers on the skin, baldness. Even with a decrease in the dose of the drug in 2 times to cope with these undesirable reactions does not work, so the drug has to be canceled.

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